FDA Enforcement
Class II
Ongoing
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.
Recall: Z-2532-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2532-2024
- Event ID
- 94909
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Artivion, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 14, 2024
- Initiation Date
- May 28, 2024
- Classification Date
- August 8, 2024
- Address
- 1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632, United States
Description
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.
Reason
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Code Info
(1) SGPH00 - Serial #12071128, exp. 17Nov2027; and serial #11586249, exp. 04May2025; UDI-DI: 00877234000461. (2) SGP020 - Serial #12658767, exp. 15Aug2028; UDI-DI: 00877234000485.
Distribution
US Nationwide distribution in the states of CA, DC, FL, and NY.
Quantity
2 arteries, 1 patch